Platelet-rich plasma plus hyaluronic acid injections for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, 1:1:1 trial enrolling 288 adults with unilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1–3) who have failed conservative therapy. All participants will have blood drawn to enable blinded procedures, then be randomized to receive a single intra-articular injection of PRP+HA, PRP alone, or HA alone. Patients, outcome assessors, and data analysts will be blinded to allocation, and PRP will be prepared from autologous whole blood for the PRP arms while the HA arm will undergo sham processing to preserve blinding. Clinical and functional outcomes and safety will be measured over scheduled follow-up visits according to the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients, aged 40 to 75 years;
2. Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
3. Unilateral involvement of symptomatology;
4. Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
5. Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
6. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
7. Ability and consent of patients to actively participate in clinical follow-up;
8. Signature of informed consent.

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
3. Patients undergoing knee surgery in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncontrolled diabetes;
7. Patients with hematological diseases (coagulopathies);
8. Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection;
9. Patients with uncompensated thyroid metabolic disorders;
10. Patients abusing alcoholic beverages, drugs or medications;
11. Body Mass Index \> 35;
12. Patients who have taken NSAIDs in the 3 days prior to blood draw;
13. Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated;
14. Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3.
15. Pregnant and/or fertile women.

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting
• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Italy Not yet recruiting

Study contacts

• Principal investigator: Davide Reale, MD — Istituto Ortopedico Rizzoli - Argenta
• Study coordinator: Davide Reale, MD
• Email: davide.reale@ior.it
• Phone: 0516366567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.